ObesityNCT04948177
Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection
An observational study of Obesity, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical records of patients who underwent intragastric botulinum toxin A from June 2019 through June 2020 at the Okan University Hospital in Istanbul were retrospectively evaluated.
Who may be able to join
- -Class I obese patients and class II obese patients with no comorbidities
Who cannot join
- Patients with type 3-4 hiatal hernia according to flap-valve grading system
- Los Angeles type B-C esophagitis
- Type I-II ulcer
- Malignant or suspected malignant lesion in stomach
- Age <18 or >70
- Patients use drugs affecting gastric contractility and pyrokinesis
- Patients have endocrine system problems (hypothyroidism and Cushing syndrome), active psychiatric disorder were not accepted as a candidate for GBI therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection in Obese Patients Class I-II With Normal Pyloric Orifice Structure: A Retrospective Analysis
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. This effect of intragastric botulinum toxin A injection (GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any obesity treatment method.
Endoscopic inspections and the complicatedness in literature results, cases that have not succeeded in losing weight after GBI might have pylorus contractility problems. Any deterioration in pylorus activity is recognized to have the potential to influence gastric emptying. In such a case, gastric emptying time would also be altered due to the paralysis of pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.
The pyloric orifice structure may have a crucial role in the success or failure of GBI therapy for obesity treatment.
Read the detailed description
The prevalence of obesity has doubled globally in the last four decades to the extent that nearly one-third of the world population is now classified as overweight/obese. Obesity causes adverse impacts on almost every physiological system in the human body and comprises an important public health problem. It is associated with an increased risk of many developing co-morbid conditions, such as diabetes mellitus, cardiovascular disease, several types of cancers, musculoskeletal disorders, and poor mental health.
Current treatment options for patients with obesity include lifestyle intervention, obesity pharmacotherapy, and bariatric surgery. The components of lifestyle intervention involve diet, exercise, and behavior modification and should be recognized as the cornerstone of any obesity treatment method; however, the impact of lifestyle intervention is limited in patients with morbid obesity.
Surgical therapies with laparoscopic approach are accepted as the most effective and persistent obesity-treatment methods, with a significant reduction in complication rates and postoperative recovery. Gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, and biliopancreatic diversion are commonly performed bariatric surgical procedures worldwide. But, the idea of scarless methods in which the video-endoscopy device is used as the primary carrier device, expecting to achieve results at least as good as laparoscopic procedures, has significantly developed within the last decade. Additionally, the development of effective and safe, newer endoscopic bariatric procedures provides another adjunctive treatment for patients with obesity who cannot handle this disease with lifestyle modification alone or who is not a candidate for surgical procedures. Endoscopic therapies, such as intra-gastric balloons, duodenojejunal bypass liners such as the EndoBarrier, and endoscopic suturing platforms, have also become proposed alternatives to surgery, considering their minimally-invasive advantages. However, given the lack of long-term data at present, the role of such devices continues to be determined.
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. This effect of intragastric botulinum toxin A injection (GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any obesity treatment method.
Endoscopic inspections and the complicatedness in literature results, cases that have not succeeded in losing weight after GBI might have pylorus contractility problems. Any deterioration in pylorus activity is recognized to have the potential to influence gastric emptying. In such a case, gastric emptying time would also be altered due to the paralysis of pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.
The pyloric orifice structure may have a crucial role in the success or failure of GBI therapy for obesity treatment.
The present study aims to explore whether there is a correlation between weight loss after GBI and pyloric orifice structure.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A: Individuals who had normal pyloric orifice structure; | |
| Group B | Group B: Individuals who have abnormal pyloric orifice structure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Change
The body mass index change in six months period is observed
Measured: 6 months
Secondary outcomes (1)
Weight change
The weight change in six months period is observed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ferhat Ferhatoglu, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948177
- Sponsor's protocol ID
- 56665618-204.01.07A
- Status last verified
- Jun 2021
- First submitted
- 19 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Gastric Fundus and Pylorus Botulinum Toxin A Injection in Obese Patients Class I-II With Normal Pyloric Orifice Structure: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04948177
- Acronym / sponsor ID
- 56665618-204.01.07A
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. This effect of intragastric botulinum toxin A injection (GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any obesity treatment method.
Endoscopic inspections and the complicatedness in literature results, cases that have not succeeded in losing weight after GBI might have pylorus contractility problems. Any deterioration in pylorus activity is recognized to have the potential to influence gastric emptying. In such a case, gastric emptying time would also be altered due to the paralysis of pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.
The pyloric orifice structure may have a crucial role in the success or failure of GBI therapy for obesity treatment.
Detailed description
The prevalence of obesity has doubled globally in the last four decades to the extent that nearly one-third of the world population is now classified as overweight/obese. Obesity causes adverse impacts on almost every physiological system in the human body and comprises an important public health problem. It is associated with an increased risk of many developing co-morbid conditions, such as diabetes mellitus, cardiovascular disease, several types of cancers, musculoskeletal disorders, and poor mental health.
Current treatment options for patients with obesity include lifestyle intervention, obesity pharmacotherapy, and bariatric surgery. The components of lifestyle intervention involve diet, exercise, and behavior modification and should be recognized as the cornerstone of any obesity treatment method; however, the impact of lifestyle intervention is limited in patients with morbid obesity.
Surgical therapies with laparoscopic approach are accepted as the most effective and persistent obesity-treatment methods, with a significant reduction in complication rates and postoperative recovery. Gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, and biliopancreatic diversion are commonly performed bariatric surgical procedures worldwide. But, the idea of scarless methods in which the video-endoscopy device is used as the primary carrier device, expecting to achieve results at least as good as laparoscopic procedures, has significantly developed within the last decade. Additionally, the development of effective and safe, newer endoscopic bariatric procedures provides another adjunctive treatment for patients with obesity who cannot handle this disease with lifestyle modification alone or who is not a candidate for surgical procedures. Endoscopic therapies, such as intra-gastric balloons, duodenojejunal bypass liners such as the EndoBarrier, and endoscopic suturing platforms, have also become proposed alternatives to surgery, considering their minimally-invasive advantages. However, given the lack of long-term data at present, the role of such devices continues to be determined.
Newly, botulinum toxin A application into the stomach has been proposed as a treatment method in obesity. It impacts through acetylcholine receptors located in smooth muscle cells and suppresses stomach motility. This method aims to decrease gastric emptying time and thus to extend the duration of feeling full. This effect of intragastric botulinum toxin A injection (GBI) makes it easier to adhere to dietary prescriptions, which is the cornerstone of any obesity treatment method.
Endoscopic inspections and the complicatedness in literature results, cases that have not succeeded in losing weight after GBI might have pylorus contractility problems. Any deterioration in pylorus activity is recognized to have the potential to influence gastric emptying. In such a case, gastric emptying time would also be altered due to the paralysis of pylorus muscles, which is one of the effect mechanisms of botulinum toxin A.
The pyloric orifice structure may have a crucial role in the success or failure of GBI therapy for obesity treatment.
The present study aims to explore whether there is a correlation between weight loss after GBI and pyloric orifice structure.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Group A: Individuals who had normal pyloric orifice structure; |
| Group B | – | –Group B: Individuals who have abnormal pyloric orifice structure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical records of patients who underwent intragastric botulinum toxin A from June 2019 through June 2020 at the Okan University Hospital in Istanbul were retrospectively evaluated.
Key inclusion criteria (1 listed)
- -Class I obese patients and class II obese patients with no comorbidities
Key exclusion criteria (7 listed)
- Patients with type 3-4 hiatal hernia according to flap-valve grading system
- Los Angeles type B-C esophagitis
- Type I-II ulcer
- Malignant or suspected malignant lesion in stomach
- Age <18 or >70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Mass Index Change
Time frame: 6 months
The body mass index change in six months period is observed
1 secondary outcome
Weight change
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index Change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.